On 7 November 2024, the FTC announced it will be sending refunds to 536,000 consumers deceived by Rejuvica’s and its owners’ unsupported claims that Sobrenix, a dietary supplement marketed and sold by Rejuvica, could reduce and eliminate alcohol cravings and consumption. In addition to the refunds, the FTC’s proposed order requests a permanent injunction and other relief due to violations under the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act of 2018

On June 13, 2024, the Supreme Court of the United States (SCOTUS) unanimously held in FDA v. Alliance for Hippocratic Medicine that plaintiff physicians and pro-life medical associations lacked Article III standing to challenge the U.S. Food and Drug Administration’s (FDA) regulation of mifepristone, a prescription drug primarily used in terminating pregnancy. Following the ruling, mifepristone remains available and approved. Also importantly, SCOTUS reasoned that a desire to make a drug less available for others does not establish standing to sue FDA. Since SCOTUS focused on standing as a threshold issue, the broader question of whether the FDA acted within its authority and jurisdiction to approve mifepristone remains unanswered.

The United States Federal Trade Commission (FTC) has again shown that social media influencers, endorsements and testimonials remain an enforcement priority. The FTC sent warning letters to two trade associations and several dieticians and other online health influencers to make clear that failure to include clear disclosures that these are paid endorsements may violate the law.

In the first three parts of this series, we provided an overview of the new US Food and Drug Administration regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the good manufacturing practices regulations FDA plans to establish, as well as the FDA draft guidance on the facility registrations and products listings. In this Part IV, we are providing an important update of FDA’s compliance policy – enforcement discretion for MoCRA facility registration and product listing until 1 July 2024, as well as the existing FDA resources to help industry prepare for MoCRA implementation.

In the first two parts of this series, we provided an overview of the new US Food and Drug Administration regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 and the good manufacturing practices regulations FDA plans to establish. In Part III, we will review the new FDA draft guidance on the facility registrations and products listings as mandated by MoCRA.

In the first part of this series, A Legal Makeover Guide for Complying with New Cosmetic Regulations under the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) Part I, we provided an overview of the new US Food and Drug Administration (FDA) ‘s regulatory requirements for cosmetics and their implementation deadlines. In this second part, we will delve into the details and look at the good manufacturing practices regulations the FDA plans to establish for cosmetic products.

Beginning 29 December 2023, the Modernization of Cosmetic Regulation Act of 2022, which was signed into law last year to establish a more strengthened US Food and Drug Administration regulatory framework to ensure the safety of cosmetic products, will begin to take effect. Like with cosmetic application, prepping for full coverage to comply with the new law is important.

On 3 April 2023, FDA issued a draft guidance for industry, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, for manufacturers whose medical devices use machine learning technologies to improve patient care. Through the draft guidance, FDA intends to provide a least burdensome approach to support iterative improvements to machine learning-enabled device software functions or ML-DSFs through modifications, while continuing to provide a reasonable assurance that the device is safe and effective. In essence, manufacturers can proactively seek FDA’s concurrence with the intended modifications to the applicable devices without additional marketing submissions for each modification in the future.

On 24 March 2023, a notice was published in the Federal Register announcing that the Food and Drug Administration published a framework for the use of digital health technologies (DHTs) in drug and biological product development. DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. FDA previously published draft guidance identifying considerations for the use of DHTs to support clinical investigations and relating to different aspects of DHT use. In the draft guidance, FDA particularly highlighted the importance of verification and validation to ensure the DHTs are for fit-for-purpose for use in the clinical investigation. Further, remote data acquisition through DHTs may raise issues including data privacy and confidentiality concerns.

On 13 March 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will no longer be in effect after expiration of the declaration of the COVID-19 public health emergency (PHE). The notice followed a Department of Health and Human Services announcement on 9 February that it is planning for the declaration of the PHE to expire on 11 May 2023.